Method For Delivery Of An Embolic Protection Unit

ABSTRACT

A method of delivering a embolic protection unit to the aorta arch of a patient. The method comprising, introducing a catheter from brachiocephalic artery or through an incision in a wall of the ascending aorta, the catheter comprising an embolic protection unit having an off-center connection point. Advancing the embolic protection unit in a downstream direction from the catheter. Expanding the embolic protection unit in the aorta arch to cover said ostia. Delivering a medical device into the ascending aorta while the embolic protection unit is hold by the catheter covering the ostia.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 14/080,703 filed Nov. 14, 2013 entitled Method ForDelivery Of An Embolic Protection Unit, which claims benefit of andpriority to U.S. Provisional Application Ser. No. 61/726,540 filed Nov.14, 2012 entitled Method For Delivery Of An Embolic Protection Unit,which is hereby incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

This invention pertains in general to the field of medical devices. Inparticular the invention relates to the positioning of catheters for thedelivery of an embolic protection unit together with a medical devicesor a medical procedure, and more specifically to the delivery of anembolic protection unit to the aorta arch.

BACKGROUND OF THE INVENTION

This section is intended to introduce the reader to various aspects ofart that may be related to various aspects of the present disclosure,which are described and/or claimed below. This discussion is believed tobe helpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

Endovascular procedures are being used more and more frequently to treatvarious cardiac and vascular surgical problems. Blocked arteries can betreated with angioplasty, endarterectomy, and/or stenting, usingminimally invasive endovascular approaches. Aneurysms can be repaired byendovascular techniques. Another use for endovascular surgery is thetreatment of cardiac valvular disease. Valvuloplasties are doneendovascularly and percutaneous valve replacement is becoming anestablished procedure. Transcatheter Aortic Heart Valve (TAVI) is aprocedure involving a collapsible aortic heart valve that can bemanipulated into place with minimally-invasive techniques.

Cerebral embolism is a known complication of such endovascularprocedures, and other cardiac surgery, cardiopulmonary bypass andcatheter-based interventional cardiology, electrophysiology proceduresetc. Embolic particles may include thrombus, atheroma and lipids, plaquefound in the diseased vessels and valves that is dislodged and resultsin embolization. Embolic particles may become dislodged by surgical orcatheter manipulations and enter the bloodstream. Dislodged embolicparticles can thus embolize into the brain downstream. Cerebral embolismcan lead to neuropsychological deficits, stroke and even death.

Prevention of cerebral embolism benefits patients and improves theoutcome of these procedures. Embolic protection devices should becompatible with the endovascular procedures, and for instance not hinderpassage through the aortic arch to the heart.

Various embolic protection devices are known in the art.

Some embolic protection devices are disclosed in WO 2012/009558 A2, orWO 2012/085916 A2, which are incorporated herein in their entirety forall purposes. However, these devices may provide iatrogenic damage tothe vessels in which they are positioned. The devices also have a ratherhigh profile in the aortic arch, limiting the endovascular procedures.

More advantageous low profile planar devices for embolic protection ofside branch vessels of the aortic arch have for instance been disclosedin WO 2010/026240 A1 or are described in international patentapplication number PCT/EP2012/058384, which are incorporated herein intheir entirety for all purposes.

The devices may however be further improved. One issue is that blood,that may include embolic particles, may impair efficiency of the devicesby bypassing across the device at the periphery thereof to the carotidarteries due to insufficient sealing at the periphery.

“Sailing” of the devices in the high pressure bloodstream ejected out ofthe heart is another issue.

Hence, notwithstanding the efforts in the prior art, there remains aneed for a further improved embolic protection devices of the type thatcan permit endovascular procedures, in particular of the heart, whileprotecting the cerebral vasculature during the procedures.

Further, in some instances a direct aorta approach TAVI procedure maystill be a preferred option, for example patients with any aortic rootangle be treated. Direct aortic access may be indicated for patientswith vessel diameters <6 mm, heavy peripheral calcification, excessivetortuosity or subclavian stenosis. The most appropriate access routeshould be selected by the cardiovascular team based on patientanatomical and clinical characteristics. Hence a protection device and adelivery device that can be used for more than one access may beadvantageous.

SUMMARY OF THE INVENTION

Accordingly, examples of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device or method according to the appendedpatent claims for providing temporary embolic protection to a patient'saortic arch vessels during medical procedures, such as cardiac surgeryand interventional cardiology and electrophysiology procedures. Embolicparticles in the aortic blood flow are prevented from entering theaortic arch side branch vessels, including the carotid arteries thatlead to the brain.

Disclosed herein are systems and methods for delivery of embolicdeflection.

According to one aspect of the disclosure, a method of delivering anembolic protection unit to the aorta arch of a patient is disclosed. Themethod comprises introducing a catheter from brachiocephalic artery orthrough an incision in a wall of the ascending aorta. The cathetercomprises an embolic protection unit having an off-center connectionpoint. The method further comprising advancing the embolic protectionunit in a downstream direction from the catheter, expanding the embolicprotection unit in the aorta arch to cover the ostia, and delivering amedical device into the ascending aorta while the embolic protectionunit is hold by the catheter covering the ostia.

Some examples of the method includes, the embolic protection unit isexpanded to a non-tubular, substantially planar shape over the ostia.

Some examples of the method includes, the catheter is introduced towardsthe cardiac valves coaxially the ascending aorta, or wherein the medicaldevice is introduced towards the cardiac valves coaxially the ascendingaorta.

Some examples of the method includes, the catheter comprises at leasttwo channels, an elongated sheath with a first channel and a secondchannel from which the embolic protection unit is expanded, the secondchannel is arranged in the first channel or around the sheath.

Some further examples of the method includes, introducing a pigtailthrough one of the channels. A pigtail catheter may be provided in suchan auxiliary side channel. The pigtail catheter may be used to furtherstabilize the catheter against the annulus of the aortic valve and innerwall of the aortic arch, such as described in WO 2012/094195 A1, whichis incorporated herein by reference in its entirety for all purposes,see in particular. A pigtail may also be used to determine were to makethe incision when performing a direct aorta approach.

Some further examples of the method includes, the second channel isarranged helically around the elongated sheath, and wherein the secondchannel has an opening directed at an angle away from an opening of thefirst channel, such as in a direction toward aorta arch when the openingof the first channel is directed towards the ascending aorta.

This arrangement may facilitate introducing and directing of thecollapsed embolic protection unit since the opening of the secondchannel is directed towards the aorta arch and not parallel with thefirst channel which may be directed coaxial with the ascending aorta,for example when performing the direct aorta approach.

Some further examples of the method includes, radially expandingexpandable units of the catheter or an elongated member positionedbeyond a distal end of the elongated sheath, to temporarily position inrelation to the valve the elongated sheath. The method further includesreleasing locking members of the catheter to maintain the elongatedsheath in a locked state, delivering a medical device through the firstchannel to the cardiac valve, releasing the locking members to returnthe elongated sheath to a relaxed state, and withdrawing the elongatedsheath in the relaxed state from the vasculature of the patient.

Some further examples of the method includes, inserting an elongatedmember with a distal end portion comprising a plurality of the radiallyexpandable units, into a lumen of the elongate sheath. Advancing theelongated member through the elongated sheath to the distal end of theelongated sheath and retracting the expandable units and withdrawing theelongated member from the lumen of the elongated sheath.

Some further examples of the method includes, making an incision in awall of the ascending aorta upstream the introduced catheter forintroducing the medical device while the embolic protection unit isprotecting the ostia.

Some further examples of the method includes, introducing the catheterin a direction towards the aorta arch and retracting the catheter afterexpanding the embolic protection unit in the aorta arch. Also,forwarding the catheter towards the cardiac valves coaxially theascending aorta and using at least one tissue apposition sustainingunit, not being a delivery shaft of the embolic protection unit, forapplication of a force offset to the connection point at the embolicprotection unit, such as a periphery, towards an inner wall of theaortic arch when the embolic protection unit is positioned in the aorticarch, such that tissue apposition of the periphery to an inner wall ofthe aortic arch is supported by the force.

This method is less iatrogenic than known methods. It provides forfurther improved sealing of the periphery of an embolic protectiondevice. It further prevents creation of debris from an ostium in theaortic arch, which might be an issue with some known embolic protectiondevices.

The supported apposition is improving apposition of the periphery to theinner wall of the aortic arch, such that the improved appositionprovides for improved sealing of the periphery against the inner wall.

The force may be applied in a substantially proximal direction relativethe device for the improved sealing.

Applying the force may include applying a tractive force by a tractionunit. The tractive force may include pulling a periphery of the deviceagainst the inner wall for locking the device in place in the aorticarch. The tractive force may be applied by at least one tether distallyconnected to the frame, periphery and/or blood permeable unit forproviding the tractive force.

The device may be delivered to the aortic arch via one of the sidevessels, such as the brachiocephalic artery from the right subclavianartery, the left carotid artery, or the left subclavian artery. It maybe delivered to the aortic arch via the descending aorta such as in afemoral approach, e.g. in a side channel of a main catheter. It may bedelivered to the aortic arch through the wall of the ascending aorta,which is an approach called “direct aorta” approach.

Applying the force includes applying a tractive force by a tractionunit, such a tether, or a pushing force by a pushing unit.

Some further examples of the method include a medical device which is abypass machine. Also, the medical device is for a TAVI procedure where astent valve is delivered while the embolic protection unit is positionedand with the catheter in the aorta arch. Alternatively the medicaldevice is a device for electrophysiology.

Some further examples of the method includes, advancing the embolicprotection unit in a downstream direction from the catheter whichcomprising, advancing a second catheter through a channel of thecatheter, the second catheter has a retractable sheath enclosing theembolic protection unit and retracting the sheath whereby the embolicprotection unit expands.

The second catheter has a distal end having a bend. This may facilitatethe directing of the second catheter if the opening of the secondcatheter is directed coaxial with the ascending aorta.

Also the method may include, introducing the catheter which includesplacing a balloon mounted on the catheter with expanding the balloon inthe ascending aorta.

The balloon is a donut shaped balloon having a filter between thecatheter and the inner ring of the donut shape.

The term “sustain” as used herein means one of support, aid, assist,keep up, uphold or the like. Sustaining a tissue apposition of a deviceaccording to the present disclosure may be provided by a push force or apull force supporting, aiding or assisting apposition, depending on thespecific examples.

The term “tether” as used herein shall not be confused with a safetytether, which is a simple safety line for allowing retrieval of anembolic protection device if needed. A tether as used herein is a lineallowing controlled tensioning of an entire embolic protection device orselected portions thereof. Traction is applied proximally to the tetherfor the providing the tensioning of the device to an inner vessel. Thetether is distally connected or attached to the embolic protectiondevice such that the traction supports anchoring of the device againstthe inner vessel wall. In this manner a fluid flow at the periphery ofthe device is controllable and can be totally stopped by the degree oftraction on the tether such that blood only passes a blood permeableunit of the device.

The device including the inventive improvement of examples, includes acollapsible embolic protection device devised for temporarytransvascular delivery to an aortic arch of a patient, the device havinga protection unit including a selectively permeable material or unitadapted to prevent embolic material from passage with a blood flow intoa plurality of aortic side branch vessels at the aortic arch, whereinthe protection unit is permanently or releasably (for assembly prior tointroduction into the body) attached to a transvascular delivery unit ata connection point or region, or an attachment point, provided at theselectively permeable unit, and a first support member for theprotection unit that is at least partly arranged at a periphery of theselectively permeable unit. In an expanded state of the device, theconnection point is enclosed by the first support member or integraltherewith, wherein the transvascular delivery unit is connectedoff-center to the protection unit at the connection point. In someexamples, the connection point or region, or attachment point, isenclosed by the first support member.

The connection point may be provided at the selectively permeable unitor at the first support member.

The connection point may be provided on a surface of the selectivelypermeable unit devised to be oriented towards the aortic side branchvessels from inside the aortic arch and at a distance from the ostiaregions when the protection unit is positioned in the aortic arch.

In some examples, the selectively permeable unit includes a firstportion devised to extend in a first direction towards a descendingaorta of the aortic arch from the connection point, and a second portiondevised to extend in a second direction, opposite to the firstdirection, towards an ascending aorta of the aortic arch from theconnection point, when the protection unit is positioned in the aorticarch, in the expanded state.

In some examples, the selectively permeable unit is arranged toasymmetrically extend from the connection point in a first directiontowards a descending aorta of the aortic arch and in a second directiontowards an ascending aorta of the aortic arch, when the protection unitis positioned in the aortic arch, in the expanded state.

The term “collapsible” used in the context of the present applicationmeans that a dimension of a device is reducible to a lesser dimensionsuch that it is arrangeable in a tubular delivery unit, such as acatheter. A collapsible unit is expandable when released or pushed outof the delivery unit. Expandable includes self expandable, e.g. by ashape memory effect and/or resilient elasticity. A collapsible unit isthe re-collapsible for withdrawal into the delivery unit and out of thepatient.

It should be emphasized that the term “including/having” when used inthis disclosure is taken to specify the presence of stated features,integers, steps or components but does not preclude the presence oraddition of one or more other features, integers, steps, components orgroups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which examples ofthe invention are capable of will be apparent and elucidated from thefollowing description of examples of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1A is a schematic illustration of an elongated sheath connected toa hemostatic valve;

FIG. 1B is a schematic illustration of an elongated member, with theradially expandable units in the collapsed configuration;

FIG. 2A is a schematic illustration of the distal end portion of theelongated member with the radially expandable units in the collapsedconfiguration;

FIG. 2B is a schematic illustration of the distal end portion of theelongated member with the radially expandable units in the expandedconfiguration;

FIG. 2C is a schematic illustration frontal view of the distal endportion of the elongated member with the radially expandable units inthe collapsed configuration;

FIG. 2D is a schematic illustration frontal view of the distal endportion of the elongated member with the radially expandable units inthe expanded configuration;

FIGS. 3A, 3B, 3C, 3D are schematic illustrations of examples of theelongated sheath in the flexible, unlocked configuration;

FIG. 3E is a schematic illustration of the cross sectional view of theelongated sheath in the unlocked state;

FIG. 3F is a schematic illustration of one example of the crosssectional view of the elongated sheath in a locked state;

FIG. 3G is a schematic illustration of another example of the crosssectional view of the elongated sheath in the locked state;

FIG. 4A is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, where an embolic protection filter isdeployed, and the sheath is in a relaxed state;

FIG. 4B is a schematic illustration where the relaxed sheath ispositioned in relation to the cardiac valve by expandable units of anelongated member extending outside the distal end of the sheath;

FIG. 4C is a schematic illustration of the cross sectional view of theelongated sheath incorporating a second channel for delivering theembolic protection filter;

FIG. 4D is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, and the sheath is in the lockedconfiguration arranged relative to an aortic cardiac valve, and theexpandable units being withdrawn after positioning the sheath;

FIG. 4E is a schematic illustration of the elongated sheath deliveredtransfemorally to a cardiac valve, where an embolic protection filter isdeployed and the sheath in the locked configuration;

FIG. 4F is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, and where the relaxed sheath ispositioned in relation to the cardiac valve by expandable units of thesheath;

FIG. 4G is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, and where an embolic protection filteris deployed over the vessels in the aortic arch via a second channel ofthe sheath;

FIG. 4H is a schematic illustration of the elongated sheath deliveredtransfemorally to a cardiac valve, and where an embolic protectionfilter is deployed over the vessels in the aortic arch via a secondchannel of the sheath;

FIG. 5 is a flowchart for a method of implanting a medical device;

FIG. 6 is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, and where an embolic protection filteris deployed over the vessels in the aortic arch via a second channel ofthe sheath;

FIG. 7A is a schematic illustration of the elongated sheath deliveringan embolic protection filter through a direct aorta access;

FIG. 7B is a schematic illustration of the elongated sheath deliveredthrough a direct aorta access to a cardiac valve, and where an embolicprotection filter is deployed over the vessels in the aortic arch via asecond channel of the sheath;

FIG. 8A is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, and where an embolic protection filteris deployed over the vessels in the aortic arch using a retractablesheath via a second channel;

FIG. 8B is a schematic illustration of the retractable sheath advancedfrom the second channel;

FIG. 8C is a schematic illustration of the retractable sheath whenretracting and the embolic protection filter is expanding;

FIG. 9A is a schematically illustration of a sheath with a secondchannel helically arranged at the sheath; and

FIG. 9B is a schematic illustration of the elongated sheath deliveredthrough a direct aorta access to a cardiac valve, and where an embolicprotection filter is deployed over the vessels in the aortic arch via asecond channel helically arranged at the sheath.

DESCRIPTION OF EMBODIMENTS

Specific examples of the disclosure will now be described with referenceto the accompanying drawings. This disclosure may, however, be embodiedin many different forms and should not be construed as limited to theexamples set forth herein; rather, these examples are provided so thatthis disclosure will be thorough and complete, and will fully convey thescope of the invention to those skilled in the art. The terminology usedin the detailed description of the examples illustrated in theaccompanying drawings is not intended to be limiting of the disclosure.In the drawings, like numbers refer to like elements.

In an example of the disclosure according to FIG. 1A, a catheter device1 for transvascular delivery of a medical device to a cardiac valveregion 6 (see e.g. FIG. 4D) of a patient is shown. The catheter devicecomprises an elongated sheath 2 with a lumen and a distal end 3. Inaddition, in FIG. 1B an elongated member 4 is provided with a distal endportion 9 comprising a plurality of radially expandable units 5. The endportion 9 may include an obturator. The expandable units 5 are arrangedfor temporarily positioning the elongated sheath 2 in relation to thecardiac valve 6, FIGS. 4B and 4F. The elongated member 4 is retractablyinsertable into the lumen of the elongated sheath 2 and the elongatedsheath 2 comprises releasable locking members for controllably lockingthe elongated sheath 2 in a shape at least partly along its length froma relaxed state (See FIG. 3B, and FIG. 4A-B, 4F) to a locked state (SeeFIG. 3C-D, and FIG. 4D-E, 4G-H) when positioned in relation to thecardiac valve 6 by the expandable units 5.

The elongated sheath 2 depicted in FIG. 1A is designed to be deliverabletransvascularly in the relaxed state which facilitates optimalflexibility when transiting through the vasculature. When at the desiredanatomical location the elongated sheath 2 is able to transit from therelaxed state to the locked state by activation of the locking members,when positioned in relation to the cardiac valve 6, as seen in FIG.4D-E, by the expandable units 5, which facilitates optimal stabilizationof the catheter 1 for subsequently affixing the medical device to theheart valve 6.

FIG. 4A shows the elongated sheath inserted in its relaxed shape. FIG.4B shows the radially expandable units 5 in their expandedconfiguration, i.e. outside the elongated sheath 2, which positions theelongated sheath 2 centrally over the valve 6. The expandable units 5expand out of the elongated member 4, which extends beyond the distalend of the sheath 2. Thereafter the elongated sheath 2 is brought to itslocked state by locking members, and the elongated member 4 isretractable from the lumen of the elongated sheath 2 together with theplurality of radially expandable units 5 when collapsed, as seen inFIGS. 4D-E. The sheath 2 is now positioned and stabilized over the valve6. This overcomes the problems in prior art with insufficientstabilization and lack of accurate positioning. Merely providing anexpandable catheter could not provide stabilization as with the lockingmembers of the sheath 2. Expandable catheters have another purpose,which is providing an accessible lumen or dilating septum punctures.Further, expandable members of previous catheters are merely forproviding aforementioned expansion and not for positioning the cathetercentrally over a valve as provided by catheter 1. When the elongatedsheath 2 is locked and, when the elongated member 4 is retracted, thelumen of the elongated sheath 2 is accessible for delivery of a medicaldevice to the cardiac valve 6 region.

Alternatively, or in addition, expandable units, such as balloons may bearranged on the outside of the sheath 2. The expandable unit may beintegrally formed with the sheath, as seen in FIG. 4F. Thus, theexpandable units do not affect the cross section of the lumen of sheath2. Upon returning to the unexpanded state, e.g. by deflating balloons ofthe expandable units 5, a delivery of a medical device through thecatheter lumen may be made without the need to retract the expandableunits 5.

The expandable units provide for a defined positioning of the distal endof the catheter sheath 2 in an anatomical structure, like a bloodvessel, an atrium or cardiac chamber, relative a cardiac valve. Thisallows for a precision delivery of a medical device through the catheterdevice. Movements of certain anatomical structures are very limited overthe cardiac cycle. For instance the aortic arch is relatively stable andthe locked catheter will stay substantially in the same spatialorientation, direction, and distance to the cardiac valve as during thefinal positioning provided by the expanded expandable units 5.

The catheter may thus be positioned relative a cardiac valve in ananatomical structure.

The catheter may be locked in the locked configuration along its entirelength. Alternatively, it may only be locked along a distal portionthereof. A distal portion may for instance be the portion arranged inthe ascending aorta, the aortic arch and the descending aorta, as shownin FIG. 4E. The catheter may comprise an embolic protection unit 8, suchas an embolic protection filter 8. The embolic protection unit 8, whenprotruding out of the second lumen 7 and being in apposition against thesurrounding vessel wall, may further contribute to stabilizing thedistal end of the locked catheter in place relative to the cardiacvalve. Hence, when the embolic protection unit 8 is expanded it willfunction as an anchor to the sheath because it prevents movement of thesheath 2 in the aortic arch due to the second channel 7, from which theembolic protection unit expands, is fixed to the sheath. The deliveryunit 13 for the embolic protection unit 8 has sufficient rigidity toallow an anchoring function for the sheath 2. The embolic protectionunit 8 provides stabilization and anchoring of the sheath 2irrespectively whether the sheath 2 is in a relaxed state or in a lockedstate. Further, the embolic protection unit 8 provides stabilization andanchoring of the sheath 2 irrespectively whether expandable units 5 areused. Hence, it is not essential for the sheath 2 to have the lockingmembers, the elongated member 4, or the expandable units 5, in order toprovide the advantageous effects as described, see further below.

FIG. 4D is a schematic illustration of the elongated sheath deliveredtransaxillary to a cardiac valve, here the aortic valve 6. The embolicprotection filter 8 is deployed, and the sheath 2 is in the lockedconfiguration arranged relative to an aortic cardiac valve 6.

FIG. 4E is a schematic illustration of the elongated sheath deliveredtransfemorally to a cardiac valve, where an embolic protection filter isdeployed and the sheath in the locked configuration.

In FIGS. 4D and 4E, the expandable units 5 are not shown, as they areeither retracted from the sheath, or returned to their low profileunexpanded/collapsed configuration in the sheath.

In FIG. 4G-H the embolic protection filter 8 is positioned over two orthree of the vessels in the aortic arch, respectively.

In all configurations shown in FIGS. 4A-B, 4D-H, the side vessels 22 areeffectively protected from embolic particles entering from the aorticarch. Embolic particles are carried with the blood flow past the embolicprotection device along the aortic arch to anatomical structures thatare less sensitive than e.g. the brain to which some of the side vessels22 lead the blood flow. Embolic protection units may be filter units inwhich the embolic particles are caught. Alternatively, or in addition,the embolic protection units may provide for the particles to slidealong the protection unit, but not pass it or fasten in it.

In examples, such as illustrated in FIG. 4A-H a catheter 1 having asecond channel 7 that extends parallel on the outer portion or the innerportion of the elongated sheath 2 is depicted. This channel 7 allows forthe delivery of further units for example an embolic protection device 8or liquids to aid the procedure to place the medical device, when thelumen of the elongated sheath 2 is used for the elongated member 4 ormedical device.

The second channel 7 may be an integral part on the inside or outside ofthe elongated sheath 2. This has the advantage of being relatively cheapto manufacture by an extrusion method.

In FIGS. 4A-H, an expandable embolic filter 8 example is depicted. Theembolic protection or filter device 8 may be extended before extendingthe aforementioned expandable units 5. This potentially enhances patientsafety by capturing any emboli such as plaque debris produced from thetreatment of a stenotic valve, and thus reduces the chance for seriouscomplications such as stroke. In these figures at least a portion of theexpandable embolic filter 8 extends from the orifice of the side channel7 through which the embolic filter 8 is passed. The embolic filter maybe of the type as disclosed in WO 2010/026240, which is incorporatedherein in its entirety for all purposes. The embolic filter unit may benon-tubular, extending substantially planar in the expanded state. Thisprovides for a compact device and efficient blocking of side branchvessels in the aortic arch from embolies. Interaction with the sidewalls in the aortic arch is therefore also kept at the minimum, avoidingscraping off further debris to be transported with the blood stream.Simultaneously, the aortic arch is kept open for unrestricted navigationof the sheath 2. Hoop shaped baskets in previous devices scrapes againstthe vessel wall and blocks a substantial portion of the navigationalspace in the aortic arch.

Extending “planar” in this context means that the thickness of thedevice is substantially smaller than the longitudinal extension thereof.Moreover, “planar” means such dimensions perpendicular to thelongitudinal extension of the protective material, that blood flowthrough the aortic arch is not hindered by the protective device.

By having a second channel in the sheath 2, the distal end of the sheathcan be positioned appropriately at the valve, by the stabilizing andanchoring effect of the protection unit 8 extending from the secondchannel, while medical device can be delivered through the lumen of thesheath without any hindrance from the protection unit 8 or e.g.expandable units such as balloons, while at the same time the sidebranch vessels of the aortic arch are protected from embolies that maybe transported in the blood stream from the procedure performed at thevalve.

The catheter device 1 may comprise a delivery unit 13 connectable to theembolic filter unit 8 at a connection point 14, as illustrated in FIGS.4G-H. The connection point 14 is arranged off-centre at the embolicfilter unit such that the delivery unit 13 is connectable off-center tothe embolic filter unit 8. The off-centre position of the embolic filterunit is advantageous for deploying it with the sheath 2 via the deliveryunit 13, while efficiently protecting the carotid arteries fromembolies, when carrying out the intervention. Blood flow is kept openefficiently by such compact device. The term “off-centre” used in thecontext of the present application means eccentric, or not arranged orlocated in a center of the device. The center is e.g. a center of acircular unit, a focal point of an elliptical unit, a point on a centerline, such as a longitudinal center line of an elongated unit, etc. Aperiphery of a unit is located “off-centre” as it is arranged at adistance in relation to a center of the unit.

The elongated member 4 may be comprised of three balloons positionedradially equidistant around the longitudinal axis (See FIG. 2C and D).Fewer or more balloons are possible, as well as alternative expansionunits such as expandable mechanical levers, or swellable units forexample retractable sponges. The expansion units 5 allow for optimalpositioning of the elongated sheath 2 in relation to the aforementionedcardiac valve 6. The multiple balloon expansion unit can be expanded(See FIG. 2D) using a variety of means for example using a fluid meansor where appropriate gaseous means. The balloons can also beindividually or simultaneously expanded as well as inflated to differingpressures independently of the other expanding units.

Alternatively, the elongated member 4 is retractably inserted into thelumen of the elongated sheath 2 to a length equal to the distancebetween the distal end 9 and the second proximal marker 10. In thisexample, proximal markers 10 and 11 are used to guide the positionalorientation of the distal end portion 9 and thus provide for optimalalignment of the expandable units 5 with the portion of the elongatedsheath 2 to be expanded. This facilitates safe positioning at thedesired valve region.

In a further example, the elongated sheath 2 is comprised of radiopaquematerial, facilitating visualization of the elongated sheath 2 whichprovides for optimal positioning of the elongated sheath 2 for deliveryof the medical device. Alternatively, radiopaque fiducial markers on theelongated sheath 2 can be used for optimal positioning of the sheath 2within the body of the patient.

The example shown in FIGS. 2A and 2B, includes a guide wire 12 which isfirstly positioned within the patient which facilitates optimal transitof the elongated sheath 2 and elongated member 4 to the desiredanatomical site.

In the examples of FIGS. 3-4, the locking units may comprise releasablelatches although any one from draw strings, squeezing mechanisms, or thelike could be envisaged as being used to lock the elongated sheath 2 ina locked state, i.e. a rigid or semi-rigid state of the sheath thatallows the sheath 2 to maintain a specific curvature, i.e. reduction inflexibility, and thereby secure its position relative to the anatomy, asseen in e.g. FIG. 4D-E. Further, thermal, electrical, magnetic orchemical properties of the material of the locking units or theelongated sheath 2 itself, may provide variable flexibility for changingbetween a locked state and a relaxed state.

In a specific example, the elongated sheath may be expanded when inlocked configuration. Releasing of locking units when the elongatedsheath 2 is in an expanded state locks the elongated sheath 2 in theexpanded state and thus retains the optimal position for medical devicepositioning through the procedure.

The locked elongated sheath 2 may be used in medical procedures todelivery of a medical device to the cardiac valve 6, which could includeartificial heart valve prosthesis, an annuloplasty device or leafletclips.

The elongated sheath 2 maybe a constituent of a medical system devisedfor transvascularly delivering a medical device to a cardiac valve 6 ofa patient. The method as depicted in FIG. 5 initially comprises 100minimally invasively either transfemorally (See FIG. 4E) ortransaxillary (See FIG. 4D) introducing a catheter 1 comprising anelongated sheath 2 with a lumen in a relaxed state into the patientsvascular system. Step 110 involves the distal end 3 of the elongatedsheath 2 being navigated through the vascular system to the desiredcardiac valve, FIG. 4A. The next step in the system 120, involves theelongated member 4 with a distal end portion 9 comprising a plurality ofradially expandable units 5, being inserted into the lumen of theelongated sheath 2, whereupon it is advanced through the elongatedsheath 2 to the distal end of the elongated sheath 2, FIG. 4B.Alternatively, expandable units 5 of the sheath may be expanded at thisstage (without introducing an elongated member 4 into the sheath, FIG.4F. Whereupon step 130 is initiated which involves the plurality ofradially expandable units 5, being radially expanded to temporarilyposition in relation to the cardiac valve 6 the elongated sheath 2, (SeeFIG. 4B and 4F).

Following positioning, the locking members of the catheter are releasedto maintain the elongated sheath 2 in a locked state (step 140). Step150 of the system can then be performed whereby the expandable units 5are then retracted and the elongated member 4 is withdrawn from thelumen of the elongated sheath 2, FIG. 4D-E. Alternatively, theexpandable units 5 of a sheath 2 are brought back to the non-expandedstate.

The embolic protection unit as shown in FIGS. 4A-H, may then be advancedout of the second channel 7. In this manner, side vessels are protectedfrom embolic material, such as debris.

A medical device can now be delivered through the lumen of the lockedelongated sheath 2 to the heart valve 6. This delivery is done with highspatial precision. Blood flow in the lumen around the locked elongatedsheath 2 is affected less than with expanded expandable units 5.

The medical device may for instance be a cardiac valve repair orreplacement device.

When the medical device is delivered, release of the locking members toreturn the elongated sheath 2 to the relaxed state can now be performed(step 160) with the subsequent withdrawal of the elongated sheath 2 inthe relaxed state from the vasculature of the patient.

The embolic protection unit as shown in FIGS. 4A-H may be retractedprior or after the release of the locking members.

Locking of the elongated sheath 2 in the locked state (FIG. 3B-D)comprises releasing the locking members for controllably locking theelongated sheath 2 when positioned in relation to the cardiac valve 6 bythe expandable units 5. This serves to retain the optimal position fordelivery of the medical device during the procedure.

To ensure the optimal positioning of the elongated member 4 when it isinserted into the elongated sheath 2, the elongated member 4 is insertedto a length which is equal to the distance between the distal end andthe second proximal marker 10 of the elongated member 4. Primarily theelongated sheath 2 will be centrally positioned in relation to thecardiac valve 6, which facilitates optimal delivery of the medicaldevice, although other positions off-center could also be desirable.

The medical system is primarily used for the delivery of a medicaldevice to be affixed to the particular cardiac valve 6, which includethe aortic and mitral valves of a patient. After delivery of the medicaldevice to the cardiac valve 6, the medical device delivery system iswithdrawn through the lumen of the locked elongated sheath 2, which maybe aided if the elongated sheath 2 is in an expanded state. Afterremoval of the medical device delivery system, the elongated sheath 2 inthe locked state transits to the relaxed state which facilitatesenhanced retraction of the elongated sheath 2.

FIG. 6 illustrates an example of using a catheter having two channels,as described herein above, for delivering a embolic protection unit fromthe brachiocephalic artery, such as from the right subclavia artery orthe right common carotid artery. The elongated sheath 2 is advanced intothe ascending aorta and may be used to deliver a medical device for amedical procedure. Medical procedures on the heart may includes at leasta step related to removal of a heart valve, the placement of aprosthetic heart valve, or repair of a heart valve. This may include thetreatment of cardiac valvular disease, like valvuloplasties includingpercutaneous valve replacement. The procedure may be TranscatheterAortic Heart Valve (TAVI) involving implantation of a collapsible aorticheart valve with minimally-invasive techniques. It may also relate tobypass, cardiac surgery, interventional cardiology or electrophysiologyprocedures.

An apposition sustaining unit may be used to apply a force offset to theconnection point at the device. Offset to the connection point may forinstance be at the periphery. It may also be adjacent the periphery. Itmay also be centrally of the blood permeable unit within the periphery.The force is applied or directed towards an inner wall of the aorticarch when the device is positioned in the aortic arch. In this mannertissue apposition of the periphery to an inner wall of the aortic archis supported by the force. For instance, a tractive force such appliedmay pull a periphery of the device against the inner wall. The forcesupports locking the device in place upon implantation.

The embolic protection device can thus be reliably placed across theapex of the aorta in order to prevent emboli from flowing into thecarotid arteries. The inventive solution is not iatrogenic, as itprevents creation of debris from e.g. ostia of side vessels. Iatrogenicrelates to an adverse condition in a patient resulting from treatment bya physician or surgeon. Arms, anchors, delivery shafts, bows, etc. ofinferior embolic protection devices, for instance extending into theside vessels, risking scraping off of plaque from the inner vessel wallor ostia, are not needed and can be avoided thanks to the presentdisclosure.

In the example of FIG. 6 a tether 40 which may run in the same channelor in other channels of the catheter as the embolic protection unit 8and be used to apply a tractive force. The apposition supporting unitmay then be an active traction unit that has for instance at least oneoperable tether distally connected at the location offset the connectionpoint. The distal connection location of the tether may be located atthe frame, periphery and/or blood permeable unit, of the embolicprotection device for providing the tractive force. The tether has oneor more distal end(s). The distal end is for instance connected to theperiphery of the embolic protection device. The tether's distal end(s)may be connected to the blood permeable unit, such as a filter ordeflector membrane. The membrane may be moved by the traction, e.g. ifthe membrane is flexible and/or elastic.

Tether(s), or more precisely, tetherline(s) are provided to control asealing degree of the periphery. Tether(s) are provided for direction ofapposition towards aortic tissue/cerebral arteries. The tether mayprovide active traction by a pull action on the tether communicated tothe embolic protection device to which it is distally connected.

The tether 40 may be arranged longitudinally movable relative thedelivery unit. In this manner, the device is positionable in the aorticarch so that the delivery device may be locked in a “delivered”position, by the delivery unit, e.g. at its proximal end at or outside aport of an introducer. The tether 40 may then still be movable andimprove sealing as described herein.

Tether(s) may be multifilament(s), which provides for a particularlyflexible solution advantageous for narrow lumen navigation.

A tether 40 may extend straight across the blood permeable unit to theforward end of the device. Thus the middle line may be pulled up and theperiphery is tensioned against the inner wall. The tether provides for alifting force to the forward end. In case the tether is guided at themiddle line, e.g. threaded through eyelets, it may provide a progressivelifting force distributed along the device.

The at least one tether 40 may be longitudinally elastic, i.e. it islongitudinally stretchable and resiliently return to a non-stretchedlongitudinal extension. The tether may be elastic along its entirelength. The tether may include one or more elastic portions or elasticelements. The elastic portion may be a helical wound portion of thetether acting as a spring. The elastic portion may be a tubular braid ofa double helically wound strands. The elastic portion may be made of anelastic material, preferably biocompatible, like rubber. In this mannerthe tractive force is variable. This may be advantageous for preventingrupture of the tether line as a non-linear extension may be “felt” by anoperator. This variable traction force may also be advantageous if thetether is tension, applying a desired traction for improving sealing ofthe embolic protection device. The tether may be locked at its proximalend in this position, e.g. extending out of an introducer port. Theelasticity may provide for compensating physiological movements of theaortic arch relative a proximal end of the device and/or tether whilemaintaining the tissue apposition. The applied force is provided withina certain range suitable to maintain the improved peripheral sealingwhile the aortic arch moves due to the beating heart and blood pulsewaves.

The blood permeable unit of the embolic protection device may have atleast one guiding unit, such as an eyelet, a tubular bent element, aroller, an open pocket fabric portion, etc. The guiding unit may receivethe tether proximally its distal end where it is attached to the device,such as at the blood permeable unit, flange, or periphery. The guidingunits, such as eyelet(s) etc. provide for locally controllableapposition at the device. The traction force may be distributed todifferent areas of the device.

The device may have an attachment point where a distal end of the tetheris connected to the device and a tractive force is transmissible via theattachment point to the device towards the periphery. Optionally one ormore radiopaque fiducial markers may be provided at the device. Afiducial marker may be provided at the attachment point. Fiducialmarkers provide for advantageous X-ray visibility and navigation,position feedback and control of the device.

In some examples, the tether is proximally extending through an ostiuminto a selected side vessel such that the tractive force centers thedevice in relation to the ostium. When pulling the tetherline 40, itpulls the device at its periphery against the inner wall of the aortafor locking the device in place. In this manner the device is selfaligning in relation to the ostium of the selected side vessel thanks tothe tether. The skilled person may provide suitable guiding units forthe tether when reading this disclosure to obtain this function.

The device may include multiple tethers distally attached along theperiphery. Alternatively, or in addition, a single proximal tetherlinemay separate distally into a plurality of (sub)tetherlines. Forinstance, a tether may be branched in the form of a Y. A single tetherto be operated proximally may then distribute a tractive force distallyvia its two distal end points to the embolic protection device.

Multiple tethers may be used or combined with tethers having multipledistal ends. The multiple tethers may be collected proximally at thedevice, e.g. at a base thereof. In this manner, the device provides fora progressive force that is evenly distributed along the periphery ofthe device. The device may in this manner advantageously adapt to theinner shape of the aortic arch. The adaptation may even more enhanced byproviding longitudinally elastic portions at the tether(s). Forinstance, the branched (sub)tetherlines may be provided of elasticmaterial, while the main line is substantially non-elastic, butflexible.

In some examples, the device may have at least one rib extending betweendifferent, preferably opposite, joints at the periphery, wherein thetether is distally attached at the rib. The tether 40 may thus apply atractive force to the rib, which in turn transfers the force to theperiphery of the device 8 towards the aortic inner wall tissue. The ribmay be a beam or yoke. It may be arranged longitudinal or transversal inrelation to the expanded device's 8 longitudinal axis.

FIG. 7A illustrates a “direct aorta” approach were an incision is madethrough the wall of the ascending aorta. This is done by making amini-sternotomy or mini-thoracotomy. In the mini-thoracotomy a incisionis made in the intercostal space. For TAVI, the direct aorta approachcan be used in patients with any aortic root angle. Direct aortic accessmay be indicated for patients with vessel diameters <6 mm, heavyperipheral calcification, excessive tortuosity or subclavian stenosis.The most appropriate access route should be selected by thecardiovascular team based on patient anatomical and clinicalcharacteristics.

In FIG. 7A, the embolic protection unit 8 is introduced into the aorticarch with one catheter 2 through an incision in the wall. A secondincision is positioned upstream the incision used for introducing amedical device or performing a medical procedure. Additionally, theembolic protection unit may have an apposition sustaining unit, such asa tether 8.

Alternatively the brachiocephalic artery may be used for introducing asheath 2 or catheter for advancing the embolic protection unit into theaorta arch while a incision is used for introducing a medical device orperforming a medical procedure.

In FIG. 7B illustrates an example of using a catheter having twochannels, as described herein above, for delivering an embolicprotection unit 8 using the direct aorta approach. The first channel 2is used for delivering a medical device or performing a medicalprocedure while the second channel 7 is used for introducing the embolicprotection unit 8. In the illustration of FIG. 7B, the appositionsustaining unit is applying a pushing force by a pushing unit 45. Apushing unit is similar to the traction, such as a tether, as describedherein above. But instead of a tractive force a pushing force is appliedfrom beneath the embolic protection unit 8. The pushing unit 45 appliespushing force against the frame, periphery and/or blood permeable unit.Thus the pushing force and presses the periphery to the inner wall. Thiscan be done either with a single wire or multiple wires (as shown in theFIG. 7B). The wires may be connected to the embolic protection unit 8 inthe same fashion as the tethers described herein.

FIG. 8A-C illustrates an example of using a catheter having two channels2 and 7 introduced from the brachiocephalic artery. In this example,when advancing the embolic protection unit 8, in a downstream directionfrom the catheter, a second catheter is pushed out of the second channel7. This second catheter has a retractable sheath 46 enclosing theembolic protection unit 8. When the retractable sheath has reach itscorrect location the sheath is retracted where after the embolicprotection unit expands.

Additionally and/or alternatively to the tether 40 illustrated in FIG.8C any type of sustaining unit can be used such as a pushing unit.

Additionally, as illustrated in FIG. 8A-C, the retractable sheath has abent distal end. This may facilitate directing the retractable sheathinto the aorta arch.

The same approach using a retractable sheath can be applied on thedirect aorta approach or when introducing an embolic protection unit 8through any of the other accesses, such as the left subclavian artery,or the descending aorta such as in a femoral approach.

FIG. 9A-B, illustrates another example of how the directing of theembolic protection unit 8 into the aorta arch may be facilitated. Inthis example, the second channel 7 is arranged helically aroundelongated sheath 2. Thus the opening 47 of the second channel may bedirected at an angle away from an opening of the first channel of theelongated sheath 2, towards the aorta arch.

Additionally, this arrangement may be used with a retractable sheath asdescribed in relation with FIG. 8A-C.

FIG. 9B illustrates a direct aorta approach but this may be used whenintroducing a catheter from the brachiocephalic artery.

Additionally to what has been described above, delivering of the embolicprotection device may be made transluminally, and delivering the firstcatheter may be performed after the delivering the embolic protectiondevice.

Delivering the first catheter may include placing a balloon mounted onthe first catheter with expanding the balloon in the ascending aorticarch to lock a distal end of the first catheter in place. The balloonmay have a donut shape having a filter between the catheter and theinner ring of the donut shape.

The embolic protection device used in the method may extends from adistal end of a second catheter or separate channel of the firstcatheter, such that the position of the embolic protection device can beindependently adjusted from the position of the first catheter.

Delivering a first catheter may be performed concurrently withdelivering the embolic protection device via a separate channel of thefirst catheter, independent of the endovascular procedure.

The present invention has been described above with reference tospecific examples. However, other examples than the above described areequally possible within the scope of the invention. Different methodsteps than those described above, may be provided within the scope ofthe invention. The different features and steps of the invention may becombined in other combinations than those described. The catheter may bepositioned and locked in other cardiac anatomical structures thanillustrated. Medical devices delivered through the catheter sheath maybe any medical device to be delivered to the cardiac valve tissue. Thescope of the invention is only limited by the appended patent claims.

1. A method of delivering an embolic protection unit to the aorta archof a patient comprising: introducing a catheter through an incision in awall of an ascending aorta of a patient, said catheter comprising anembolic protection unit having an off-center connection point; advancingsaid embolic protection unit in a downstream direction from saidcatheter; expanding said embolic protection unit in an aorta arch tocover an ostia of the patient; delivering a medical device into theascending aorta while said embolic protection unit is held by saidcatheter covering said ostia; and making an incision in a wall of theascending aorta upstream of said introduced catheter for introducingsaid medical device while said embolic protection unit is protectingsaid ostia.
 2. The method according to claim 1, wherein said embolicprotection unit is expanded to a non-tubular, substantially planar shapeover said ostia.
 3. The method according to claim 1, wherein saidcatheter is introduced towards a cardiac valve coaxially in saidascending aorta, or wherein said medical device is introduced towardssaid cardiac valve coaxially in said ascending aorta.
 4. The methodaccording to claim 1, wherein said catheter comprises an elongatedsheath with a first channel and a second channel from which said embolicprotection unit is expanded, said second channel is arranged within saidfirst channel or said catheter comprises an elongated sheath with afirst channel and a second channel is arranged around said elongatedsheath.
 5. The method according to claim 4, comprising introducing apigtail through one of said channels.
 6. The method according to claim4, wherein said second channel is arranged helically around saidelongated sheath, and wherein said second channel has an openingdirected at an angle away from an opening of said first channel in adirection toward the aorta arch when said opening of said first channelis directed towards the ascending aorta.
 7. The method according toclaim 4, further comprising, radially expanding expandable units of saidcatheter or an elongated member positioned beyond a distal end of saidelongated sheath, to temporarily position in relation to said valve saidelongated sheath; releasing locking members of said catheter to maintainsaid elongated sheath in a locked state; delivering a medical devicethrough said first channel to said cardiac valve; releasing said lockingmembers to return said elongated sheath to a relaxed state; andwithdrawing said elongated sheath in said relaxed state from thevasculature of said patient.
 8. The method according to claim 7 furthercomprising, inserting an elongated member with a distal end portioncomprising a plurality of said radially expandable units into said firstchannel of said elongated sheath; advancing said elongated memberthrough said elongated sheath to said distal end of said elongatedsheath; retracting said expandable units and withdrawing said elongatedmember from said first channel of the elongated sheath.
 9. The methodaccording to claim 17, wherein said supported apposition is improvingapposition of said periphery to said inner wall of said aortic arch,such that said improved apposition provides for improved sealing of saidperiphery against said inner wall.
 10. The method according to claim 9,wherein said force is applied in a substantially proximal directionrelative said device for said improved sealing.
 11. The method accordingto claim 17, wherein applying said force includes applying a tractiveforce by a traction unit or a pushing force by a pushing unit.
 12. Themethod according to claim 1, wherein said medical device is a bypassmachine.
 13. The method according to claim 1, wherein said medicaldevice is for a TAVI procedure where a stent valve is delivered whilesaid embolic protection unit is positioned and with said catheter insaid aorta arch.
 14. The method according to claim 1, wherein saidmedical device is a device for electrophysiology.
 15. The methodaccording to claim 1, wherein advancing said embolic protection unit ina downstream direction from said catheter comprises, advancing a secondcatheter through a channel of said catheter, said second catheter has aretractable sheath enclosing said embolic protection unit; retractingsaid sheath whereby said embolic protection unit expands.
 16. The methodaccording to claim 15, wherein said second catheter has a distal endhaving a bend.
 17. A method of delivering an embolic protection unit toan aorta arch of a patient comprising: introducing a catheter from abrachiocephalic artery or through an incision in a wall of an ascendingaorta of the patient, said catheter comprising an embolic protectionunit having an off-center connection point; advancing said embolicprotection unit in a downstream direction from said catheter; expandingsaid embolic protection unit in the aorta arch to cover an ostia of thepatient; delivering a medical device into the ascending aorta while saidembolic protection unit is held by said catheter covering said ostia;and introducing said catheter in a direction towards said aorta arch;retracting said catheter after expanding said embolic protection unit insaid aorta arch; forwarding said catheter towards a cardiac valvecoaxially in said ascending aorta; and using at least one tissueapposition sustaining unit, not being a delivery shaft of said embolicprotection unit, for application of a force offset to said connectionpoint at said embolic protection unit towards an inner wall of saidaortic arch when said embolic protection unit is positioned in saidaortic arch such that tissue apposition of a periphery to an inner wallof said aortic arch is supported by said force.
 18. A method ofdelivering an embolic protection unit to an aorta arch of a patientcomprising: introducing a catheter from a brachiocephalic artery orthrough an incision in a wall of an ascending aorta of the patient, saidcatheter comprising an embolic protection unit having an off-centerconnection point; advancing said embolic protection unit in a downstreamdirection from said catheter; expanding said embolic protection unit inthe aorta arch to cover an ostia of the patient; and delivering amedical device into the ascending aorta while said embolic protectionunit is held by said catheter covering said ostia; wherein saidintroducing said catheter includes placing a balloon mounted on saidcatheter and expanding said balloon in the ascending aorta; and whereinsaid balloon is a donut shaped balloon having a filter between saidcatheter and an inner ring of said donut shape.